induction chemo-nivo in unresectable stage iii nsclc

Conditions: Lung Cancer, Nonsmall Cell; Lung Cancer Stage III

Summary: the purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.


Eligibility criteria:
inclusion criteria: * squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage iiia-iiic (8th edition ajcc) and not previously treated * pd-l1 level needs to be measured with values 0-100% eligible * egfr/alk/ros1 wild type or unknown genetic alterations in these genes * ecog performance status ≤ 1 * adequate organ and marrow function * adequate pulmonary reserve (e.g., fvc, fev1, tlc, frc, and dlco) capable of tolerating the proposed lung resection * human immunodeficiency virus (hiv)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months * for patients with evidence of chronic hepatitis b virus (hbv) infection, the hbv viral load must be undetectable on suppressive therapy, if indicated * patients with a history of hepatitis c virus (hcv) infection must have been treated and cured. for patients with hcv infection who are currently on treatment, they are eligible if they have an undetectable hcv viral load. * patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen * clinical risk assessment of cardiac function using the new york heart association functional classification class 2b or better * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment * any prior radiotherapy to the lung * any prior treatment for nsclc * any prior therapy with anti-pd-1, anti-pd-l2, anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways * any history of a severe hypersensitivity reaction to any monoclonal antibody * any history of allergy to the study drug components * primary tumors involving the esophagus * pancoast tumors * patients cannot have primary tumors which would remain unresectable * history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab or other agents used in study * any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications * ongoing requirement for systemic corticosteroids greater than the equivalent of prednisone 10mg * previous malignancies * history of interstitial lung disease * patients requiring continuous supplemental oxygen * use of any live vaccines against infectious diseases (e.g., influenza, varicella. etc.) within 4 weeks (28 days) of initiation of study therapy * active systemic infection requiring therapy * patients with uncontrolled intercurrent illness * patients with psychiatric illness/social situations that would limit compliance with study requirements * pregnant or lactating women

Keywords: nivolumab unresectable